Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Group A | Group A will receive standard, routine medical care. If you are randomized to standard, routine medical care you will need to communicate with your Doctor and clinical care team through conventional methods such as over the phone or through MyChart. | 0 | None | 11 | 143 | 12 | 143 | View |
| Group B | Group B will be asked to use the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients randomized to use the Health Loop app will be able to communicate with their Doctor and clinical care team directly through the app. Patients will also participate in mobile and web-based surveys, receive reminders related to their healthcare, and receive information personalized to their treatment plan. HealthLoop mobile application: Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care. | 1 | None | 14 | 127 | 10 | 127 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Gastrointestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| GI distress | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Manipulation under anesthesia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Effusions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Transverse myelitis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Suture abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hiccups (hospitalized) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |